DQ

Version: 1.0

Risk Analysis - Stretchbander

Machine type
Machine number
Customer

S 3015 - Stretchbander
1100117
Bosnalijek d.d., Bosnia-Herzegovina

Uhlmann Pac-Systeme
GmbH & Co. KG
Uhlmannstrae 14-18
88471 Laupheim, Germany
Phone +49 (0)7392 702-0
Fax +49 (0)7392 702-18972
validierung@uhlmann.de
www.uhlmann.de

Approval Uhlmann Pac-Systeme

Name

Position

Date

Signature

Date

Signature

Prepared
Reviewed
Approved

Approval Bosnalijek d.d., Bosnia-Herzegovina

_

Name

Position

Approved
Approved

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Contents List
1.

Preface .................................................................................................................................... 3

2.

Introduction ............................................................................................................................ 4

3.

Definition of terms ................................................................................................................. 4

4.

Handling of Document........................................................................................................... 5

5.

Listing of Functions............................................................................................................... 6

6.

References.............................................................................................................................. 6

7.

Revision History Summary ................................................................................................... 6

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1. Preface
Dear customer
The Risk Analysis is a highly complex procedure and represents the starting point for all qualification activities.
This document has been prepared using the assembly descriptions and the Hardware and Software Design Specifications relevant for this particular type of machine.
This document for risk analysis has been prepared by a team of people in order to cover all aspects and all possible risks.
The team consisted of the following members:
Electrical engineers
Mechanical engineers
Validation manager
Members of the after-sales service
The present document is copyrighted. In compliance with the provisions of the copyright law, the
present printout is not permitted to be copied or transferred onto another medium in whole or in
part without the prior written consent of Uhlmann Pac-Systeme Germany.
Authorized copies must bear the same copyright and property notices as the original. In line with
the interpretation of the law, translations will be considered as copies.

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2. Introduction
The Risk Analysis is an integral part of the documented production safety in the pharmaceutical
industry today.
The intention of the FDA and cGMP guidelines is to enhance drug safety by strictly observing the
basic principle stipulated by the WHO of ensuring the proper manufacture and quality of drugs.

3. Definition of terms
Within the present document, the following terms will be used:
Risk Analysis is the systematic examination of all functions being part of a process, the analysis
of possible failures and their effects as well as the consequences ensuing thereof.
Installation Qualification (IQ) is the formal and systematic evidence that the major features of
system installation (hardware and software) are in conformity with agreed specifications and that
the instructions and recommendations made by suppliers have been observed.
Operation Qualification (OQ) is the formal and systematic evidence that the equipment or system functions faultlessly and operates as expected throughout the range of applications.

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4. Handling of Document
Example for assessing machine functions:
Critical:

The failure/function is relevant for the packages and

correct operation has to be proved by means of a test.

Not critical:

The failure/function is not relevant for the packages

and therefore no further steps have to be taken.

Document set-up:
No.:

Consecutive number

Assembly:

Name of the assembly.

Failure/Function:

Description of the failure that may occur on the assembly or function.

Failure effect:

Description of the effect the failure may have.

Detected by machine:

Indicates whether the failure will be detected by the

machine controller.

Risk assessment:

Critical or not critical.

Comments:

Comments on risk assessment.

IQ test:

In this column, it is stated whether an IQ test is available for the

listed failure/function.

OQ test:

In this column, it is stated whether an OQ test

is available for the listed failure/function.

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5. Listing of Functions
No.

Assembly

Error/function

Failure effect

Det. by
mach.

Risk
Assessment

Comments

IQ Test

OQ Test

Yes
/ No

No.

Yes
/ No

No.

General
items

Conformity of machine numbers

No

Critical

Equipment of the machine with the item stipulated in the order confirmation is ensured only if
the machine numbers on
the rating plate and on
the order confirmation
are indentical.

Yes

IQ_GENE
RAL
ITEMS
1.0

No

General
items

Correct installation
of main components

No

Critical

A flawless operation of
the machine is ensured
only if the main components have been correctly delivered and installed.

Yes

IQ_GENE
RAL
ITEMS
1.1

No

General
items

Complete technical
documentation

No

Critical

Critical The technical

documentation must be
complete in the order to
ensure a correct operation of the machine

Yes

IQ_GENE
RAL
ITEMS
1.3

No

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No.

Assembly

Error/function

Failure effect

Det. by
mach.

Risk
Assessment

Comments

IQ Test

OQ Test

Yes
/ No

No.

Yes
/ No

No.

General
items

Complete validation
documentation

No

Critical

For validation of the machine, all validation documents must be available

as specified in the order.

Yes

IQ_GENE
RAL
ITEMS
1.4

No

General
items

Correct line voltage

No

Critical

The line voltage must be

in conformity with the
supplier's specification
and with local regulations.

Yes

IQ_GENE
RAL
ITEMS 1.5

No

General
items

Compressed air
supply

No

Critical

Operation of the machine

is permitted only if the
compressed air supply is
in conformity with the
supplier's specification.

Yes

IQ_GENE
RAL
ITEMS 1.6

No

General
items

Consistency of item
designations

No

Critical

All items of the machine

equipment must be unequivocally identified by
an item designation
which must correspond
to that mentioned in the
wiring diagram.

Yes

IQ_GENE
RAL
ITEMS
1.7

No

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No.

Assembly

Error/function

Failure effect

Det. by
mach.

Risk
Assessment

Comments

IQ Test

OQ Test

Yes
/ No

No.

Yes
/ No

No.

Supply of
services

Compressed air
monitoring

Machine will
stop or machine start is
disable

Yes

Critical

A correct execution of the

process is not ensured.

IQ sensors
& actuators

01.01.01

Safety
guards

Warning safety
guard 1 open

Production is
not possible if
guard is open

Yes

Critical

Product quality as well as

a correct execution of the
processes can be ensured only if the guards
are closed.

IQ_GENE
RAL
ITEMS 1.8

01.02.01

10

Safety
guards

Warning safety
guard 2 open

Production is
not possible if
guard is open

Yes

Critical

Product quality as well as

a correct execution of the
processes can be ensured only if the guards
are closed.

IQ_GENE
RAL
ITEMS 1.8

01.02.02

11

Safety
guards

Warning safety
guard 3 open

Production is
not possible if
guard is open

Yes

Critical

Product quality as well as

a correct execution of the
processes can be ensured only if the guards
are closed.

IQ_GENE
RAL
ITEMS 1.8

01.02.03

12

Safety
guards

Warning safety
guard 4 open

Production is
not possible if
guard is open

Yes

Critical

Product quality as well as

a correct execution of the
processes can be ensured only if the guards
are closed.

IQ_GENE
RAL
ITEMS 1.8

01.02.04

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No.

Assembly

Error/function

Failure effect

Det. by
mach.

Risk
Assessment

Comments

IQ Test

OQ Test

Yes
/ No

No.

Yes
/ No

No.

IQ sensors
& actuators

01.03.02

01.04.01

13

Control
cabinet

Temperature monitoring control cabinet

Machine
stops, the
temperature
in the control
cabinet has
risen above
the limit

Yes

Critical

The temperature exceeds the permitted ambient temperature for the

components fitted. A correct operation is not ensured any more.

14

Machine
operation

Emergency stop
active
(TouchPanel)

Machine
stops in undefined position

Yes

Critical

Products may be damaged if processes are not

completed.

15

Machine
operation

Warning test run

A warning
window appears on the
screen

Yes

Not
Critical

01.04.13

16

Machine
operation

Reference drive
(TouchPanel)

A fault appears on the

Touch Panel

Yes

Not
Critical

Remove all products out

of the machine

01.04.14
01.04.15

17

Line operation

Downstream machine stopped

Machine
stops, product
transfer to
downstream
machine is
impossible

Yes

Critical

Stretch bander must stop

to prevent a product jam
and damage to the product

01.06.01

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& actuators

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No.

Assembly

Error/function

Failure effect

Det. by
mach.

Risk
Assessment

Comments

IQ Test

OQ Test

Yes
/ No

No.

Yes
/ No

No.

18

Line operation

Link up is turned off

Machine
stops

Yes

Critical

Stretch bander must stop

to prevent a product jam
and damage to the product

IQ sensors
& actuators

01.06.02

19

Control
cabinet

Frequency converter infeed conveyor not ready

Infeed conveyor not running

Yes

Critical

No product feeding of the

previous machine to the
strechbander machine.

IQ sensors
& actuators

02.01.01

20

Infeed

Jam at infeed

A cycle stop
will be triggered if fault
product inquiry infeed.

Yes

Critical

Products may be damaged if light sensor work

not correctly

IQ sensors
& actuators

02.01.02

21

Control
cabinet

Frequency converter erecting station not ready

Erecting station not running

Yes

Critical

No product feeding of the

previous machine to the
strechbander machine.

IQ sensors
& actuators

02.01.03

22

Infeed
pusher

Infeed pusher not in

front position

Run time control will stop

the machine.

Yes

Critical

Products may be damaged if processes are not

completed

IQ sensors
& actuators

02.01.04

23

Infeed
pusher

Infeed pusher not in

rear position

Run time control will stop

the machine.

Yes

Critical

Products may be damaged if processes are not

completed

IQ sensors
& actuators

02.01.05

24

Stacker

Stacker not in lower

position

Run time control will stop

the machine.

Yes

Critical

Products may be damaged if processes are not

completed

IQ sensors
& actuators

02.02.02

25

Stacker

Stacker not in up-

Run time con-

Yes

Critical

Products may be dam-

IQ sensors

02.02.03

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No.

Assembly

Error/function

Failure effect

per position

trol will stop

the machine.

Det. by
mach.

Risk
Assessment

Comments

IQ Test

OQ Test

Yes
/ No

Yes
/ No

No.

aged if processes are not

completed

No.
& actuators

26

Sealing
bar

Film sealing

Product between sealing

bar

Yes

Critical

Products may be damaged if light sensor work

not correctly

IQ sensors
& actuators

02.03.02

27

Sealing
bar

Temperature of film
sealing

Irregular film
sealing

Yes

Critical

Product quality as well as

a correct execution of the
processes can be ensured only if the sealing
bar works correctly.

02.03.03
02.03.04

28

Sealing
bar

No function of sealing bar

Machine
stops, sealing
is impossible

Critical

Sealing bar heating off,

this will be detected by
the machine.

02.03.05

29

Sealing
bar

Sealing bar not in

lower position

Run time control will stop

the machine.

Yes

Critical

Products may be damaged if processes are not

completed

IQ sensors
& actuators

02.03.06

30

Sealing
bar

Sealing bar not in

upper position

Run time control will stop

the machine.

Yes

Critical

Products may be damaged if processes are not

completed

IQ sensors
& actuators

02.03.07

31

Sealing
bar

Tear control

Machine
stops

Yes

Critical

A broken film at the sealing bar will be detected.

02.04.01

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No.

Assembly

Error/function

Failure effect

Det. by
mach.

Risk
Assessment

Comments

IQ Test

OQ Test

Yes
/ No

No.

Yes
/ No

No.

32

Control
cabinet

Frequency converter film drive top

not ready

Upper film
drive not running

Yes

Critical

The film drive above dispence no film.

IQ sensors
& actuators

02.04.02

33

Control
cabinet

Frequency converter film drive

bottom not ready

Lower film
drive not running

Yes

Critical

The film drive below dispence no film.

IQ sensors
& actuators

02.04.03

34

Filmdrive
top

Monitoring dispence film top

Run time control will stop

the machine.

Yes

Critical

The film dispence is not

correctly

IQ sensors
& actuators

02.04.04

35

Filmdrive
bottom

Monitoring dispence film bottom

Run time control will stop

the machine.

Yes

Critical

The film dispence is not

correctly

IQ sensors
& actuators

02.04.05

36

Film drive

Warning film running out

An acustic
signal and a
warning window appears

Yes

Not
Critical

Replenish film.

IQ sensors
& actuators

02.04.06
02.04.07

37

Outward
transfer

Outward point not

closed

Run time control will stop

the machine.

Yes

Critical

Products may be damaged if the sensor work

not correctly

IQ sensors
& actuators

02.06.03

38

Quality
control

Products in carton
or carton itself is
damaged

Damaged
carton or
product will be
produced

No

Critical

After format changeover

the cartons or products
may be damaged because of wrong settings

06.01.01
06.01.02

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6. References
For preparation of the present document, the following guidelines and technical documents have
been used as reference:

Wiring diagrams S 3015

PLC software S 3015
TouchPanel error texts S 3015
GAMP Guideline

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7. Revision History Summary

Version

Date

Chapter

Reason

Name

1.0

25.05.2009

First release

A. Arbeiter

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